Recruiting

Lower-Limb Exoskeleton

Sponsor:

VA Office of Research and Development

Code:

NCT05926596

Conditions

Spasticity

Movement Disorders

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Wearable Robotic Exoskeleton

Study Details

Brief summary:

The purpose of this research study is to develop a protocol using a fully wearable, portable lower-limb exoskeleton for improving leg and walking function in people with movement disorders. The study investigates the effects of wearing the device during a set of experiments including leg stretching, treadmill walking and overground walking in muscle activity, joint motion, and gait performance. The goal is to develop an effective lower-limb strategy to restore lost leg function (e.g., range of motion) and gait ability, and improve quality of life in people with movement deficits following a neurological disorder.

Conditions

Spasticity

Movement Disorders

Spinal Cord Injury

Study ID

NCT05926596

Start date

Feb 9, 2026

Status verified date

Feb, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Veteran individuals with spasticity due to spinal cord injury (SCI) at least 6 months post SCI
  • Capable of providing informed consent and reporting age, gender, and neurological condition
  • Neurologically stable (>6 months post-SCI) and can wear the device and the sensors, provide written informed consent, and follow instruction

Exclusion Criteria:

  • Participants should not experience another neurological disorder except their primary diagnosed neurological condition (spinal cord injury)
  • Participants should not be pregnant
  • Participants should weigh less than 300 lbs
  • Participants should not have experienced signs of hip/knee pain during the past 2-3 weeks that limits mobility (i.e., reaching, walking, lifting, etc.)
  • Participants should be recovered from any previous surgical interventions, joint injuries, muscle strain, or extreme muscle soreness following surgery
  • Participants should not take medications known to affect bone metabolism, muscle strength or cardiovascular performance or have any ailments causing high fever, high blood pressure, or high heart rate

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Robotic Exoskeleton

All participants will be interfered with a wearable robotic exoskeleton.

Interventions

Wearable Robotic Exoskeleton

  • Participant preparation, placement of wearable sensors and monitoring, and wearable device fitting.
  • Lower-limb joint rotations and leg stretching protocol (40-60 minutes). The wearable exoskeleton and its control algorithm are evaluated to rotate leg joints and apply stretching similarly to the forces applied by nurses and caregivers when providing manual forces. Joint rotation and limb stretching is conducted while participants sit down (e.g., in a wheelchair, on a chair, on one side of a bed, or on a clinical mat) or lay down on a bed/mat. The protocol involves ankle plantarflexion and dorsiflexion, knee extension, hip flexion with the knee flexed, and toe flexion and extension (bilaterally) assisted by the exoskeleton, and each movement is repeated at a low-to-moderate rate of 10-30 cycles/minute.
  • Treadmilll and Overground Walking (60-90 minutes including rest periods)
  • Cool down (5-10 minutes)

Primary outcome measure

  • 3D postures [ Time Frame: Through study completion, an average of 24 weeks ]
  • Joint angles [ Time Frame: Through study completion, an average of 24 weeks ]
  • Joint angular velocities [ Time Frame: Through study completion, an average of 24 weeks ]

Central Contacts and Locations

Central contacts

Steven W Brose

(315) 425-4400steven.brose@va.gov

Locations

Syracuse VA Medical Center, Syracuse, NY

Recruiting

Syracuse, New York, United States, 13210-2716

Contacts

Steven W Brose

315-425-4400steven.brose@va.gov

Principal Investigator:

Steven W Brose

More Information

Sponsor

VA Office of Research and Development

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • exoskeleton
  • spasticity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-02-23.